AstraZeneca LP (NYSE: ATC) today announced that it has reached a $2.4 billion settlement with Pfizer Inc., the world’s largest drug maker, for an alleged global price increase in the drug’s Crestor® anti-cholesterol drug.
This settlement resolves allegations that AstraZeneca illegally marketed Crestor® (rosuvastatin calcium) to consumers and companies who purchased the drug, and then marketed it to consumers and companies who bought it to increase their revenue.
“We are pleased to announce that we have reached an agreement with Pfizer that resolves our recent price increase,” said Dr. Sidney Wolfe, director of the Center for Drug Evaluation and Research at the Food and Drug Administration. “Pfizer is proud of the substantial savings that we’ve achieved through the acquisition of Crestor® in the United States, and will continue to vigorously pursue this important drug.”
Pfizer Inc. and its competitors, including AstraZeneca, are responsible for the development of the drug. In November 2003, Pfizer initiated a marketing campaign to market the drug in the United States, and it was the first drug that was approved for marketing in the United States. Pfizer, along with competitors, launched a television campaign to market the drug in the United States.
The settlement resolves a number of allegations made against AstraZeneca that led to the price increase. AstraZeneca purchased Crestor® from Pfizer, which had an estimated market value of $4.6 billion. Pfizer, along with competitors, entered into a settlement agreement with AstraZeneca to resolve the drug’s alleged price increase.
AstraZeneca was the world’s largest drugmaker and one of the largest healthcare providers, with sales of approximately $4.1 billion for the U. S. market.
Pfizer has been a leader in the anti-cancer drug market since 1993 and the largest drug maker in the world. In 2002, Pfizer acquired a majority share in AstraZeneca’s AstraZeneca portfolio, making it one of the most successful pharmaceutical companies in the world. In 2010, the company had $2.3 billion in sales for the U.
Pfizer’s price increase was due to an ongoing battle over the timing of Crestor® price increases. On July 1, 2003, the FDA issued an interim warning that a significant price increase in Crestor® was not appropriate. In December 2003, the FDA announced that it had granted approval to sell Crestor® for a treatment of chronic obstructive pulmonary disease (COPD).
On June 2, 2005, the FDA issued a revised warning to AstraZeneca about the price of Crestor® in the United States, which would result in an increase of more than $1.5 billion in direct costs to the company. The price increase resulted in a $1.4 billion price increase in the U.
On April 26, 2009, the U. Food and Drug Administration approved a marketing authorization for Crestor® based on a new warning that AstraZeneca had been required to inform its U. sales representatives. The new warning includes: “In order to assure that the product will be effective and safe for use, the drug should not be used for patients with certain conditions, including those that can cause serious and potentially fatal side effects, such as high cholesterol, hypertension, or heart failure, in combination with certain drugs.”
The new warning applies to Crestor® and is only applicable to AstraZeneca’s products.
In its announcement, the FDA said, “In evaluating the drug, AstraZeneca has evaluated the potential benefits, risks, and costs of a new, generic version of the drug. The FDA believes that it has determined that the new warning is appropriate and has approved the treatment for AstraZeneca in accordance with the instructions of the FDA.
“Under the new warning, AstraZeneca will continue to market the generic version of Crestor® for the treatment of chronic obstructive pulmonary disease.”
According to AstraZeneca, the new warning does not apply to Crestor® and the drug is not approved for human use.
Crestor works by reducing a certain enzyme within the body that produces cholesterol. It belongs to a class of medications called statins.
Cholesterol is a form of lipid, a waxy substance that helps your body make cells, vitamins, and certain hormones. It is not inherently bad. Your liver produces an enzyme that synthesizes cholesterol to help with the above healthy functions. Additional cholesterol is introduced to the body through certain foods like meat, poultry, and dairy products.
There are two types of cholesterol: high-density lipoproteins (HDLs) and low-density lipoproteins (LDLs). LDLs carry cholesterol throughout the body, delivering cholesterol to cells that need it. HDLs carry excess LDLs back to the liver, where they are broken down and flushed from the body. While LDLs play a key role in cell health, they build up when the body has more cholesterol than the cells need. This buildup turns into plaque in the arteries (blood vessels). As plaque covers the artery walls, the blood vessels become narrow. This makes it harder for blood to flow through the body, which can lead to heart disease and heart failure.
Statins work by reducing the production of cholesterol in the liver, which lowers the overall cholesterol levels in the body. Not only do statins decrease levels of LDLs in the body, but they can also raise the level of HDLs in the body. In effect, they keep the body from making too much of the “bad” cholesterol that builds up in arteries while increasing the amount of “good” cholesterol that carries the “bad” out of the body. This dual action has been shown, along with diet and exercise, to lower overall cholesterol levels in patients effectively.
Crestor (Rosuvastatin) is a generic medication often used to treat patients who have high cholesterol levels, or those with liver disease, as well as other patients with gastrointestinal symptoms such as ulcers. In combination with food, rosuvastatin can reduce cholesterol levels in the body.Benefits of taking Crestor:
Side effects of Crestor:
Check with your doctor:
A slow, low-fat diet, regular physical activity, engaging in other lifestyle changes, avoiding processed foods, and using topical or oral medications may help reduce the severity of the side effects. Also, regular check-ins with your doctor to make sure you’re fully compliant with your medicine’s label.
The cost of Crestor can vary from $80 to $90 per month, depending on the type of medicine you purchase and where you purchase it from. For example, a 90-day supply of Crestor may cost anywhere from $20 to $30 per month, depending on the pharmacy and whether you purchase it from an online pharmacy or your local retailer. Some online retailers offer competitive pricing, while others may charge a premium for the best deals. Talk to your health care provider to determine the best course of action for you.
In some cases, your health care provider may recommend starting a new prescription while purchasing Crestor. This may reduce the risk of side effects and ensure your dosage remains the same over time. To ensure your dosage remains the right choice for you, talk to your health care provider about adjusting the dosage of any new medications you are taking.
For example, if you are taking Crestor for enlarged prostate, your doctor may prescribe a lower dose of Crestor to reduce the risk of side effects. However, if you are taking Crestor for an autoimmune condition, your doctor may adjust the dosage accordingly. This ensures your Crestor dosage remains the right one to you.
In general, the cost of Crestor can vary depending on the type of medicine you purchase and the pharmacy you use. Some online retailers may charge a premium for the best deals, while others may use discounts or special offers.
When buying Crestor online, it’s important to exercise caution and only purchase it from reputable sources. Here’s a general overview of the cost of Crestor:
It’s always a good idea to compare prices at different online retailers before making a purchase. While Crestor is generally considered a cost-effective option for many people, it’s essential to exercise caution and only purchase from reputable sources.
When buying Crestor online, it’s important to exercise caution and only purchase from reputable sources.
In the last decade, the development of a number of clinical and experimental studies on the use of statins (Lipitor and Crestor) has become a subject of increasing interest. Among these, some have been published in the scientific literature, mainly regarding the efficacy of these statins [
,
].
In the United States, several statin studies have been published. For example, in a retrospective case-control study, a statin that reduces LDL cholesterol levels (Lipitor, Crestor, Crestor-M) and increases HDL cholesterol levels (Lipitor, Crestor, Crestor-D) appears to be superior to a statin with no effect on blood pressure [
In a prospective cohort study, the safety of statins in the prevention of cardiovascular disease (CVD) and type 2 diabetes was evaluated in 985 patients with Hiatal Staging 1-2 years after a total of 931, ie, those without CVD and type 2 diabetes who had been treated for 10 years with or without statins [
The safety of statins in the prevention of cardiovascular disease (CVD) and type 2 diabetes is also well established. A meta-analysis showed that a statin with a combined oral statin dose of 40 mg daily was associated with a reduction in the risk of stroke [
In a prospective cohort study, a statin that reduces LDL cholesterol levels (Lipitor, Crestor, Crestor-M) and increases HDL cholesterol levels (Lipitor, Crestor, Crestor-D) appeared to be superior to a statin with a total of 100 mg daily. However, it was concluded that the drug was associated with adverse events in the patients who were not treated with either statin or placebo, including gastrointestinal (GI) adverse events [
In a meta-analysis of randomized clinical trials of patients with Hiatal Staging 1-2 years after a total of 2,069, ie, those with mild or moderate Hiatal Staging 1-2 years after the completion of a total of 5,086, patients, the overall incidence of serious adverse events (AEs) and serious adverse events associated with the use of statins was 1.8% [
In the first study, a statin that reduces LDL cholesterol levels (Lipitor, Crestor, Crestor-M) and increases HDL cholesterol levels (Lipitor, Crestor, Crestor-D) appeared to be superior to a statin with a total of 100 mg daily. However, it was concluded that the drug was associated with adverse events in the patients who were not treated with either statin or placebo, including GI adverse events [
In the last decade, several case reports and meta-analyses have been published on the use of statins, including those that are related to lipid lowering and cardiovascular safety. In those cases, the safety of the statins was established [
], but the incidence of serious adverse events was low [
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